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Class 2 Device Recall Model DMLC IVErgo, Dynamic Multileaf Collimator |
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Date Initiated by Firm |
May 01, 2013 |
Date Posted |
February 25, 2014 |
Recall Status1 |
Terminated 3 on January 29, 2015 |
Recall Number |
Z-0978-2014 |
Recall Event ID |
65309 |
510(K)Number |
K001163
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Product Classification |
Block, beam-shaping, radiation therapy - Product Code IXI
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Product |
DMLC IV-ERGO
Product Usage: Intended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometrical volumes of specific shape containing pathology to be treated so that adjacent non-diseased tissues are spared to the extent possible.
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Code Information |
Identifier : 116001, 116012, 116044, 116055, 116014, 116052, 116023, 116056, 116053, 116043, 116047, 116051, 116122, 116063, 116068, 116013, 116046 |
Recalling Firm/ Manufacturer |
Elekta, Inc. 400 Perimeter Center Ter Ne Ste 50 Atlanta GA 30346-1227
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For Additional Information Contact |
Linda Wetsel 770-300-9725
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Manufacturer Reason for Recall |
It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems
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FDA Determined Cause 2 |
Component design/selection |
Action |
Elekta sent an Important Field Safety Notice letter dated May 2013 to affected customers. The letter identified the scope, problem, clinical impact, solution, and safety reference. For question call +44 (0)1293 544422 |
Quantity in Commerce |
35 units |
Distribution |
US Nationwide Distribution in the states of CT, FL, GA, IA, MO, NY, ND, OK, RI, TX, VA, WA |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = IXI and Original Applicant = 3D LINE USA, INC.
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